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Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?

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ClinicalTrials.gov Identifier: NCT01730846
Recruitment Status : Completed
First Posted : November 21, 2012
Results First Posted : December 20, 2017
Last Update Posted : February 20, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Sherry McKee, Yale University

Brief Summary:
The purpose of this study is to examine whether doxazosin will attenuate the ability of stress to precipitate smoking lapse behavior in treatment seeking daily smokers. Participants will participate in a smoking cessation attempt after the laboratory sessions.

Condition or disease Intervention/treatment Phase
Smoking Drug: Doxazosin 4mg/day Drug: Placebo Drug: Doxazosin 8mg/day Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?
Study Start Date : February 2013
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: Doxazosin 4mg/day
doxazosin 4mg/day
Drug: Doxazosin 4mg/day
4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
Other Name: Cardura

Placebo Comparator: Placebo
placebo control
Drug: Placebo
Placebo

Experimental: Doxazosin 8mg/day
doxazosin 8mg/day
Drug: Doxazosin 8mg/day
8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
Other Name: Cardura




Primary Outcome Measures :
  1. Latency (Min) to Initiate Ad-lib Smoking Session [ Time Frame: 0 up to 50 minutes (Delay Period) ]
    Latency to start smoking in the stress and neutral ad-lib smoking lab sessions. Subjects had the opportunity to delay smoking for 50 minutes (delay period). Once the subject decides to smoke, the 1 hour ad-lib smoking session begins. They can chose to smoke as little or as much as they wish.


Secondary Outcome Measures :
  1. Number of Cigarettes Smoked During Ad-lib Session [ Time Frame: 60 minutes (ad-lib smoking period) ]

    Number of cigarettes smoked during the stress and neutral ad-lib smoking period.

    Once the subject decides to smoke (delay period), the 1 hour ad-lib smoking period begins. They can chose to smoke as little or as much as they wish.




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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 18-60
  • Able to read and write English
  • Smoker
  • Motivated to Quit Smoking

Exclusion Criteria:

  • Any significant current medical conditions that would contraindicate smoking
  • Current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) abuse or dependence of other substances, other than nicotine dependence or alcohol abuse
  • Positive test results at intake appointment on urine drug screens for illicit drugs
  • Past 30 day use of psychoactive drugs including anxiolytics and antidepressants
  • Women who are pregnant or nursing
  • Suicidal, homicidal or evidence of current severe mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders
  • Participants who have donated blood within the past 6 weeks
  • Individuals who are currently taking other medications prescribed for smoking cessation
  • Specific exclusions for administration of doxazosin or any alpha blocker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730846


Locations
United States, Connecticut
Yale Center for Clinical Investigations, Yale University
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Sherry A McKee, PhD Yale University

Responsible Party: Sherry McKee, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT01730846     History of Changes
Other Study ID Numbers: 1111009293
R21DA033597 ( U.S. NIH Grant/Contract )
First Posted: November 21, 2012    Key Record Dates
Results First Posted: December 20, 2017
Last Update Posted: February 20, 2018
Last Verified: January 2018

Keywords provided by Sherry McKee, Yale University:
smoking lapse behavior
smoking cessation
doxazosin
medication effect on smoking lapse behavior
medication effect on smoking cessation
stress

Additional relevant MeSH terms:
Doxazosin
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs